Contents:

1 Focus, Objectives and Methodology 1.1 Report Focus 1.2 Report Objectives 1.2.1 Industry Obstacles 1.2.2 The Road to Regulatory Standards 1.3 Report Methodology 2 Introduction to Biogenerics 2.1 Approval of Biogenerics 2.2 Establishment of Bioequivalence 2.2.1 Facilitating Bioequivalence Table 2.1 Drugs That Must Demonstrate in Vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution 2.2.2 Manufacturing Under Sameness 2.2.3 Generics/Biogenerics Definitions 2.2.4 FDA Approval for Generic Biologics 2.2.5 Criteria for Therapeutically-Equivalent Products 2.2.6 Differing Characteristics in Therapeutics Equivalence 2.3 Bioavailability and Bioequivalence Definitions 2.4 CDER Bioequivalence Codes 2.4.1 In Vitro Bioequivalence 3 Follow-on Biologics 3.1 Resemblance to Innovative Products 3.1.1 How Innovators and Follow-ons Differ 3.1.2 Intramanufacture Comparability 3.1.3 Complexity in Generic Biopharmaceutical Manufacture 3.1.4 Approval Process for Biologics 3.1.5 Legal and Regulatory Framework Creation 4 Components of Potential Success and Stumbling Blocks 4.1 Shortsightedness of the Hatch-Waxman Act 4.2 Production Difficulty 4.3 Challenges for Biogenerics 4.4 Poorly Defined Definitions 4.5 Determining Comparability Pre- and Post-manufacturing Changes 4.6 Drawbacks for Generic Manufacturers 5 Financial Potential of Biogenerics Table 5.1 Biopharmaceuticals Nearing Generic Exposure 5.1 Europe's Generic Sales as a Barometer for Future Biogeneric Growth Table 5.2 Factors Influencing Germany's Favorable Operating Environment 5.2 Opportunities for Growth 5.3 Patent Terminations 6 Factors Influencing Market Potential 6.1 European Guidance 6.1.1 Complexity of Biosimilars Production 6.1.2 EMEA and FDA Guidelines 6.2 Rising Health Costs and Biogenerics 6.2.1 Governmental Measures to Promote Generics 6.3 Increasing Costs of Biologics 6.4 Beating High Prescription Costs with Biogenerics 7 Generic Industry Challenges 7.1 Manufacturing Difficulties and Capacity Shortages 7.1.1 Innovative Research and Development 7.1.2 Profit-margin Comparisons 7.1.3 NCE R&D Programs 7.2 Pliva's Success 7.3 Teva Focuses on NCE Products 7.4 IVAX Increases NCE Pipeline 7.5 Balancing NCE Activities and Generics 8 Biogenerics Market Potential for Products with Current Expired Patents 8.1 Eliminating Federal Barriers 8.1.1 Clinical Data Transference 8.1.2 Non-competitive Flow of Information 8.2 Competitive Innovators and Follow-on Manufacturers 8.2.1 Clinical Properties' Differences 9 Biogenerics Market Potential for Products with Future Expired Patents Table 9.1 Blockbuster Biotechnology Products With Patent Expiry Before 2007 Table 9.2 Biotech Products with Generic Equivalents Under Development 9.1 High-Profile Biotech Products at Risk of Biogeneric Competition 9.1.1 Humulin Table 9.3 Sales of Humulin 2000-2003 9.1.1.1 Threats to Humulin 9.1.2 Intron A Table 9.4 Sales of Intron A 2000-2003 9.1.2.1 Threats to Intron A 9.1.3 Procrit Table 9.5 Sales of Procrit 2000-2003 9.1.4 Epogen Table 9.6 Sales of Epogen 1999-2003 9.1.4.1 Next Generation 9.1.5 Neupogen Table 9.7 Sales of Neupogen 2002-2003 9.1.5.1 Next Generation 9.2 Final Thoughts 10 Impediments to Biogenerics Market Development 10.1 Sandoz Files Suit Against the EC 10.2 Europe Takes Lead in Regulatory Procedure 10.3 FDA Considers Abbreviated Approval System 10.4 Interchangeability Table 10.1 Factors That Could Hinder Generics' Production 10.5 Complexity of Biotech Patents 10.6 Bio-giant Genentech Weighs In 10.7 Manufacturing Differences Resulting in Clinical Properties Differences 10.8 Challenges to the Production of Generic Equivalents 10.9 Proof of Comparability 10.10 Confusion Over Constitution of Generic Biologics 10.11 Detecting and Quantitating Impurities in Biologics 10.12 Specifications for Processes and Products 10.13 Demonstrating Safety and Efficacy in Biogenerics 10.14 Impurities in Follow-on Products 10.15 Data for Licensing Follow-ons 11 Regulatory and Legislative Issues 11.1 Annexe I revision 11.2 Regulation of "Biosimilars" 11.3 Initital Legal Framework 11.4 Additional Guidance Documents 11.5 Industry Reaction 11.6 CDER and EMEA Requisites for Biogeneric Approval 11.7 FDA Addresses Solutions to Regulatory Challenges 11.7.1 Comparability Protocols Table 11.1 Submitted Data to Demonstrate Bioavailability 11.8 In Vivo Bioequivalence Testing 11.9 Two One-sided Test Procedure 11.9.1 Bioequivalence Methodology 11.10 Protecting the Patient Through Regulation 11.11 Case Study: Sandoz and Omnitrop 11.11.1 Proving Bioequivalence 11.11.2 Omnitrop Could Set Precedents for FDA Approval Table 11.2 Omnitrop's Recent History 11.11.3 Sandoz Leads the Way 11.12 Licensing for Biologics 11.13 FDA Requirements for Biotech Drugs 11.14 Clinical Studies for Biogenerics' Approval 11.15 Direct Comparison Between Biologics 11.15.1 FDA Draft Guidance 12 Company Profiles and Activity 12.1 Stada 12.1.1 Uncertain Future Table 12.1 Stada's Strengths 12.2 Cangene 12.2.1 Cangene Waits for Next Big Wave 12.2.2 Human Growth Hormone 12.2.3 Therapeutical Equivalence for rhGH 12.3 Teva 12.3.1 Teva and Active Biotech Table 12.2 FDA-approved Generic Drugs Marketed by Teva Pharmaceutical 12.3.2 Teva and Savient Involved in HGH Court Case 12.3.3 Copaxone 12.3.4 Teva Acquires Dorom 12.4 GeneMedix Table 12.3 GeneMedix's Biogeneric Pipeline 12.5 Ivax 12.6 Microbix 12.7 Rhein Biotech 12.8 BioPartners GmbH 12.9 Transkaryotic Therapies (TKT) 12.10 BioGeneriX Appendix I Table I Therapeutic Biologics Under the Auspices of the Center for Drug Evaluation and Research (CDER) Appendix II CBER (Center for Biologics Evaluation and Research)-Licensed Establishments and Products Appendix III EU Guidance Appendix IV Data Exclusivity Legislation Table II Survey of Worldwide Data Exclusivity Legislation